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Riata Products
- Starting date:
- November 28, 2011
- Posting date:
- January 9, 2012
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-15114
Recalled products
- Riata ST Active Fixation Dual Coil LCD Lead (Steroid Eluting)
- Riata ST Active Fixation Integrated Bipolar ICD Lead
- Riata Passive Fixation True Bipolar ICD Lead
- Riata Passive Fixation Tachyarrhythmia Lead (Steroid Eluting)
- Riata Active Fixation Tachyarrhythmia Lead (Steroid Eluting)
- Riata Single Coil Passive Fixation Lead (Steroid Eluting)
- Riata Single Coil Active Fixation Lead (Steroid Eluting)
- Riata I Passive Fixation Lead (Steroid Eluting)
- Riata I Active Fixation Lead (Steroid Eluting)
Reason
Riata and Riata ST silicone leads have demonstrated a high rate of externalized conductors, i.e. interior, ethylene tetrafluoroethylene (ETFE) covered, lead conductor wires extruding from the device lumen into the intravascular space.
Affected products
A. Riata ST Active Fixation Dual Coil LCD Lead (Steroid Eluting)
Lot or serial number
- Not Applicable
Model or catalog number
- 7000
- 7001
- 7002
Companies
- Manufacturer
-
St-Jude Medical
Cardiac Rhythm Management Division
B. Riata ST Active Fixation Integrated Bipolar ICD Lead
Lot or serial number
- Not Applicable
Model or catalog number
- 7010
- 7011
Companies
- Manufacturer
-
St-Jude Medical
Cardiac Rhythm Management Division
C. Riata Passive Fixation True Bipolar ICD Lead
Lot or serial number
- Not Applicable
Model or catalog number
- 7040
- 7041
- 7042
D. Riata Passive Fixation Tachyarrhythmia Lead (Steroid Eluting)
Lot or serial number
- Not Applicable
Model or catalog number
- 1570
- 1571
Companies
- Manufacturer
-
St-Jude Medical
Cardiac Rhythm Management Division
E. Riata Active Fixation Tachyarrhythmia Lead (Steroid Eluting)
Lot or serial number
- Not Applicable
Model or catalog number
- 1580
- 1581
Companies
- Manufacturer
-
St-Jude Medical
Cardiac Rhythm Management Division
F. Riata Single Coil Passive Fixation Lead (Steroid Eluting)
Lot or serial number
- Not Applicable
Model or catalog number
- 1572
Companies
- Manufacturer
-
St-Jude Medical
Cardiac Rhythm Management Division
G. Riata Single Coil Active Fixation Lead (Steroid Eluting)
Lot or serial number
- Not Applicable
Model or catalog number
- 1582
Companies
- Manufacturer
-
St-Jude Medical
Cardiac Rhythm Management Division
H. Riata I Passive Fixation Lead (Steroid Eluting)
Lot or serial number
- Not Applicable
Model or catalog number
- 1560
- 1561
- 1562
Companies
- Manufacturer
-
St-Jude Medical
Cardiac Rhythm Management Division
I. Riata I Active Fixation Lead (Steroid Eluting)
Lot or serial number
- Not Applicable
Model or catalog number
- 1590
- 1591
- 1592
Companies
- Manufacturer
-
St-Jude Medical
Cardiac Rhythm Management Division